Device Classification Name |
radioimmunoassay, parathyroid hormone
|
510(k) Number |
K874299 |
Device Name |
N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA) |
Applicant |
INCSTAR CORP. |
1990 INSUSTRIAL BLVD. |
P.O. BOX 285 |
STILLWATER,
MN
55082 -0285
|
|
Applicant Contact |
LISA J STONE |
Correspondent |
INCSTAR CORP. |
1990 INSUSTRIAL BLVD. |
P.O. BOX 285 |
STILLWATER,
MN
55082 -0285
|
|
Correspondent Contact |
LISA J STONE |
Regulation Number | 862.1545
|
Classification Product Code |
|
Date Received | 10/20/1987 |
Decision Date | 11/23/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|